142 Chapter 5 Frontiers and Future research opportunities Osia® System (Cochlear, Mölnlycke, Sweden) At the forefront of current developments is the new Osia® System (Cochlear, Mölnlycke, Sweden), Seen by some, as the panacea for active transcutaneous BCHDs. This transcutaneous device comprises of a piezo power transducer and magnet, implanted under intact skin. The external sound processor sends signals via electromagnetic induction. The Osia® system requires no bony surgical well creation and utilises a single BI300 osseointergated fixture to secure it to the temporal bone. The combination of a minimally invasive procedure along with the absence of significant bony remodeling, makes this an attractive option for children. A recent review of medical device reports in the USA has demonstrated a 2.1% complication rate in more than 1500 implantations [23] which suggests favorable outcomes when compared to other active devices such as the bone bridge, and percutaneous options. In the paediatric setting, research is currently limited. However, the evidence reported to date report an overall successful, uncomplicated placement with excellent audiologic outcomes [24]. Repeated processor connectivity issues have been reported and represent a potential area for future device development [25]. Further follow-up and comparative studies with other BCHDs are necessary to fully evaluate the effectiveness of the Osia® system in children and this would be an excellent avenue for future study. Vibrant Soundbridge - MED-EL, Innsbruck, Austria An alternative rehabilitation option to BCHDs are the exciting developments in middle ear implants. Introduced into the market in 2002, the Vibrant Soundbridge (VSB) (MED-EL, Innsbruck, Austria) provides an alternative method to directly stimulate the inner ear. The Vibrant Soundbridge consists of two primary components: a Vibrating Ossicular Prosthesis (VORP 503) and the SAMBA 2 audio processor which provide electromagnetic, direct-drive amplification. The VORP is surgically implanted under the skin and its floating mass transducer is coupled to the ossicular chain, commonly the long process of incus or placed in contact with the oval window, round window, or stapes head. Signal are passed from the processor via the magnetic coupling, this signal is then converted to movement of the floating mass transducer and directly stimulates the inner ear. It has been designed for people with mild to severe sensorineural hearing loss, as well as for those with conductive or mixed hearing loss. The VBS performance in adults is well reported and meta-analysis in 2016 highlighted its benefits particularly with regards to mixed hearing loss and failed previous tympanoplasties when classical ossiculoplasty could not provide enough functional gain [26].
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